About this trial
This is a multicenter prospective observational study aimed at evaluating the role of an ultrasonographic score in monitoring disease activity in patients with Takayasu arteritis (TAK). Patients with active disease, either at new diagnosis or during relapse, will undergo serial vascular US assessments during follow-up according to routine clinical practice at each participating centers. For each patient, an OMERACT-derived US score (OTUS) will be calculated. This score was developed and preliminarily validated in previous phases of a multistep project endorsed by OMERACT (Outcome Measures in Rheumatology), an international initiative focused on the development and validation of outcome measures in rheumatology. The study hypothesis is that this score is sensitive to change over time and can be used to monitor disease activity and predict outcome in patients with TAK.
Eligibility criteria
Qualifiers
Age ≥18 years
Male and female
Diagnosis of TAK according to the 1990 ACR and/or 2022 ACR/EULAR classification criteria
Clinical domain: new onset or worsening of clinical signs and/or symptoms attributable to TAK;
Disqualifiers
Inability or contraindication to undergo vascular US
Severe comorbidities limiting participation or follow-up
Concomitant conditions that may confound ultrasound findings (e.g., significant atherosclerosis requiring intervention, complete occlusion of one of the arterial segments under investigation)
Diagnosis of another rheumatologic disease
Trial design
Treatments tested in this trial
- Not listed
Trial groups
Locations
Sponsors and collaborators
IRCCS San Raffaele
Lead sponsor
Azienda USL Reggio Emilia - IRCCS
Collaborator
University Hospital Padova
Collaborator